Solution · IEC 62304
For medical-device software under IEC 62304, Microfilm captures verification testing as it happens and signs each record, tracing every test to the requirement and software item it verifies — so the verification thread is maintained as part of the design record, not rebuilt for a review.
Medical-device software under IEC 62304 has to show that each requirement was verified and traceable through the software lifecycle. Microfilm captures verification testing as it happens, signs each record, and traces it to the requirement and software item it covers — so your verification evidence is part of the design record, not a separate scramble.
Availability · Capture and signing are free forever on the desktop app. The self-building traceability matrix and audit-package export are Team-and-up cloud features.
What Microfilm is · Microfilm is a desktop app and cloud service that records software QA testing as it happens and turns it into signed, tamper-evident, audit-ready evidence — readable by both human auditors and AI coding agents.
Microfilm produces the verification records an IEC 62304 process needs; it is not a certification and does not establish your software safety classification or design controls for you. Your lifecycle processes and conformity assessment remain your responsibility.
The problem
IEC 62304 expects a clear thread from software requirements through verification, maintained across the lifecycle. When verification evidence lives in scattered screenshots and a matrix re-keyed by hand before a review, the trace is fragile: it’s slow to assemble, easy to break, and hard to prove was maintained as the software changed.
How Microfilm fits
A verification test links to the software requirement and the software item it covers, so the thread from requirement to verification evidence is maintained as the work happens — not reconstructed for a design review.
Verification evidence is signed at execution and written to an append-only log, attributed to the person who ran it — the integrity a medical-device design record is expected to hold.
When software changes, the record shows when a verification last passed, who ran it, and what they saw — so you can demonstrate verification was maintained, not just performed once.
Export the traceability matrix and signed verification evidence as a structured package that slots into your design history — without reopening sessions or rebuilding the trace by hand.
The evidence
An IEC 62304 verification record in Microfilm links a software requirement to the software item and the verification test that covers it, the result, who attested it, and the append-only signature behind it. It is the maintained, attributable verification thread a design review expects — captured as the work happens rather than re-keyed before the audit.
FAQ
No. Microfilm produces the verification records a 62304 process relies on — traceable, signed, and attributable. Your software safety classification, lifecycle processes, design controls, and conformity assessment remain your responsibility.
Verification tests link to the software requirement and item they cover, and the links stay live as software changes. The record shows when each verification last passed and who ran it, so you can demonstrate the trace was maintained, not rebuilt for a review.
Yes. Each record is signed at execution and written to an append-only log, attributed to the person who ran the verification — the integrity expected of a design record.
Capture and signing are free on the desktop app. The self-building traceability matrix and audit-package export are cloud capabilities on the Team plan and up.
Create a workspace for your team, or download the free capture app and record your first session.